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Study on Isatuximab and Dexamethasone for Patients with Relapsed Multiple Myeloma Undergoing Stem Cell Transplantation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Relapsed Multiple Myeloma, which is a type of blood cancer that returns after treatment. The study will explore the effectiveness of a treatment involving two medications: Isatuximab and Dexamethasone. Isatuximab is a monoclonal antibody, which is a type of protein designed to target specific cells, and Dexamethasone is a corticosteroid, which helps reduce inflammation and suppress the immune system.

The purpose of the study is to evaluate how well these medications work together in treating patients with relapsed multiple myeloma. Participants in the study will receive these medications through intravenous infusions, which means the drugs are delivered directly into the bloodstream through a vein. The study will also include a process called autologous hematopoietic stem cell transplantation, where a patient's own stem cells are used to help restore healthy blood cells after treatment.

Throughout the study, participants will be monitored to assess the response to the treatment and any side effects. The study aims to determine the rate of minimal residual disease (MRD) negativity, which indicates the absence of cancer cells in the body, within 12 months after the stem cell transplantation. The trial will also look at other outcomes, such as the overall response rate and the time it takes for the disease to progress. The study is expected to continue until early 2027.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient provides written consent and undergoes initial assessments to confirm eligibility. These assessments include blood tests to check platelet count, neutrophil count, calcium levels, liver function, and kidney function.
Female patients must confirm they are not pregnant and agree to use effective birth control during the study and for five months after the last dose. Male patients must agree to use contraception during the study and for five months after the last dose.
Step 2
Initial treatment phase
The patient receives isatuximab and dexamethasone as part of the initial treatment. Isatuximab is administered intravenously as a solution for infusion. Dexamethasone is given in various forms: as an injectable solution and as oral drops.
The specific dosage and frequency of administration are determined by the study protocol and the patient's condition.
Step 3
Stem cell transplantation
After the initial treatment phase, the patient undergoes autologous hematopoietic stem cell transplantation. This involves using the patient's own previously collected stem cells to restore bone marrow function.
The goal of this phase is to achieve a response in the treatment of relapsed multiple myeloma.
Step 4
Maintenance therapy
Following transplantation, the patient enters the maintenance therapy phase. This phase involves continued administration of isatuximab to help maintain the response achieved from the initial treatment and transplantation.
The frequency and duration of maintenance therapy are specified in the study protocol.
Step 5
Monitoring and follow-up
Throughout the study, the patient undergoes regular monitoring to assess the effectiveness of the treatment and to check for any side effects. This includes blood tests and other assessments as needed.
The study aims to evaluate the rate of minimal residual disease (MRD) negativity and other response criteria over a period of up to 12 months after transplantation.
Step 6
End of study participation
The patient's participation in the study concludes after the final assessments are completed. The study is estimated to end in January 2027.
The results of the study will contribute to understanding the effectiveness of isatuximab and stem cell transplantation in treating relapsed multiple myeloma.

Who can join the trial?

18 criteria

The patient must have given voluntary written informed consent to participate in the study.
The patient must have a **platelet count** of at least 50 x 10⁹/L (or at least 30 x 10⁹/L if more than 50% of the bone marrow is affected by myeloma) within 14 days before starting the study medication. **Platelets** are small blood cells that help with clotting.
The patient must have an **absolute neutrophil count (ANC)** of at least 1 x 10⁹/L without using growth factors. **Neutrophils** are a type of white blood cell important for fighting infections.
The patient must have a **corrected serum calcium** level of 14 mg/dL (3.5 mmol/L) or lower. **Calcium** is a mineral in the blood that is important for bone health and other body functions.
The patient must have an **alanine transaminase (ALT)** level that is 3 times the upper limit of normal (ULN) or lower. **ALT** is an enzyme found in the liver, and high levels can indicate liver damage.
The patient must have a **total bilirubin** level that is 2 times the ULN or lower. **Bilirubin** is a substance made during the breakdown of red blood cells, and high levels can indicate liver problems.
The patient must have a **creatinine clearance** of at least 30 mL/minute. **Creatinine clearance** is a measure of kidney function.
Female patients can participate if they are not pregnant, not breastfeeding, and meet one of the following conditions:
They are not of childbearing potential.
If they are of childbearing potential, they must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for at least 5 months after the last dose.
Male patients must agree to use contraception during the study and for at least 5 months after the last dose and must not donate sperm during this time.
The patient must be willing and able to attend study visits and follow the study procedures.
The patient must be between 18 and 70 years old.
The patient must have a life expectancy of at least 3 months.
The patient must have received an **autologous stem cell transplant (ASCT)** as the first treatment and experienced a progression or relapse after at least 24 months. **ASCT** is a procedure where a patient's own stem cells are used to replace damaged or destroyed bone marrow.
The patient must have received certain treatments for the first relapse, excluding those containing anti-CD38 antibodies, and achieved at least a partial response according to specific criteria.
The patient must have at least 2.0 x 10⁶ CD34+/Kg cryopreserved autologous stem cells. **CD34+** cells are a type of stem cell important for blood formation.
The patient must have an **ECOG Performance Status** score of 0 or 1, which indicates they are fully active or have some symptoms but do not require bed rest. **ECOG Performance Status** is a scale used to assess how a disease affects a patient's daily living abilities.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy
Verified
Ospedale San Raffaele S.r.l.
Milan, Italy
Responsive
Universita Degli Studi Di Roma La Sapienza
Rome, Italy

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Investigated drugs

Isatuximab
is a medication used in this clinical trial to treat patients with relapsed multiple myeloma. It is a type of therapy that targets specific proteins on the surface of cancer cells, helping the immune system to identify and destroy these cells. This medication is being studied to see how effective it is in combination with other treatments for multiple myeloma.
Autologous Hematopoietic Stem Cell Transplantation (ASCT)
is a procedure used in this trial for patients with relapsed multiple myeloma. In this process, a patient's own stem cells are collected, stored, and then given back to the patient after intensive treatment. This helps to restore the bone marrow and immune system, allowing the patient to recover from the effects of high-dose chemotherapy. The study aims to evaluate the effectiveness of this procedure when used alongside isatuximab.

What is already known about the treatment

Isatuximab – Isatuximab is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its effectiveness in treating relapsed multiple myeloma, a type of blood cancer. The medication works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. Isatuximab is classified as a monoclonal antibody, which is a type of targeted therapy designed to attack cancer cells more precisely.

Investigated diseases

Relapsed Multiple Myeloma – This is a type of blood cancer that occurs when plasma cells in the bone marrow grow uncontrollably. It is characterized by the return of the disease after a period of improvement or remission. The disease can cause bone pain, anemia, kidney dysfunction, and increased susceptibility to infections. As it progresses, patients may experience more frequent relapses and shorter periods of remission. The condition can lead to complications such as bone fractures and high calcium levels in the blood. It is a chronic condition that requires ongoing management to control symptoms and disease progression.